Zimmer biomet complaint (b)(4).Concomitant medical product: item 25-1005x, lot 068020; steriletrac system x-drive thinflap 2 hole straight plate.Report source: foreign: (b)(6).A visual inspection was conducted on the returned product per inspection criteria.The packaging was then opened to further investigate the total pieces of debris and a single hair could be seen inside the sterile pack.The complaint is confirmed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Root cause is attributed to a manufacturing issue.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2022-00050.
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